ASTM-F639 2003

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F639-98a(2003) Standard Specification for Polyethylene Plastics for Medical Applications

Published By	Publication Date	Number of Pages
ASTM	2003	4

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Categories: 11.120.01 - Pharmaceutics in general, 83.080.20 - Thermoplastic materials, ASTM

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Description

1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) intended for use in medical device applications involving human tissue contact devices, short term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.

1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Additional information

Standard Title	F639-98a(2003) Standard Specification for Polyethylene Plastics for Medical Applications
Published Code	ASTM
Publication Date	2003
Pages Count	4
ICS Codes	11.120.01 - Pharmaceutics in general 83.080.20 - Thermoplastic materials

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ASTM-F639 2003

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